Phase 4
N=72
A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01159938 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast — 10.99; 10.73; 11.56; 11.31 meters per second (m/s) — p=0.617
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lispro (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast |
10.99; 10.73; 11.56; 11.31; 10.41; 10.15 | 0.617 |
| PRIMARY Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast |
10.19; 10.38; 10.26; 10.22; 10.12; 10.53 | 0.676 |
| PRIMARY Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast |
10.96; 10.76; 11.18; 10.61; 10.74; 10.92 | 0.724 |
| PRIMARY Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast |
10.99; 11.28; 11.04; 11.47; 10.95; 11.09 | 0.466 |
| PRIMARY Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast |
11.09; 11.57; 10.99; 11.16; 11.19; 11.98 | 0.275 |
| SECONDARY Change in Pulse Wave Amplitude (PWA) |
-4.4; -4.1; -0.6; -2.3; -2.5; -2.9 | 0.024 sig |
| SECONDARY Change in Peripheral Artery Tonometry (PAT) |
0.03; 0.09; 0.11; 0.36; -0.05; 0.15 | 0.905 |
| SECONDARY Change in QT Interval on Electrocardiogram (ECG) |
12.1; 23.8; 6.5; 11.0; 11.3; -0.4 | — |
| SECONDARY Change in Blood Glucose (BG) |
0.07; 4.98; 3.39; 5.59; 3.23; -0.15 | — |
| SECONDARY Change in Postprandial Pulse Wave Velocity (PWV) |
-0.26; -0.74; -0.91; -0.52; 0.22; 0.25 | — |
Summary
This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.
Eligibility Criteria
Inclusion Criteria
- Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
- Have not smoked in the last 12 hours prior to the study visit.
- Have albuminuria but normal kidney function or normal UAER [UAER < 20 micrograms per minute (mcg/min) or < 30 milligrams/24 hours (mg/24h), respectively]. Participants with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
- Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
- Each participant must understand the nature of the study and must sign an informed consent document (ICD).
Healthy participants are eligible to be included in the study only if they meet all of the following criteria:
- Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
- Normal glucose tolerance and normal UAER (UAER between < 20 μg/min in the overnight urine collection or < 30 mg/24h in the 24-h urine collection).
- Healthy participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
- Each healthy participant must understand the nature of the study and must sign an ICD.
Exclusion Criteria
Participants/healthy participants will be excluded from the study if they meet any of the following criteria:
- Have had a cardiovascular event [stroke, myocardial infarction (MI), coronary artery procedure (by-pass surgery or angioplasty), limb amputation due to ischemia, peripheral vascular disease] or coronary heart disease confirmed by exercise test or scintigraphy.
- Have arrhythmias.
- Have an acute infection.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.
Data sourced from ClinicalTrials.gov (NCT01159938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.